Sekisui Diagnostics, Spectrolyse PAI-1 In-Vitro Diagnostic Use for the quantitative determination of Plasminogen Activat
FDA device recall Z-0463-2013 · posted 2012-12-03 · Terminated
Recall details
- Recalling firm
- Sekisui Diagnostics Llc
- Reason for recall
- Spectrolyse PAI-1 activity assay, producing lower than expected absorbance values 0 IU/ml standard reducing the slope of the standard curve requiring more frequent sample dilutions.
- Action taken
- Sekisui Diagnostics issued an "URGENT PRODUCT RECALL NOTICE" dated October 24, 2012 to all consignees. The letter instructed consignees to immediately stop using the specified lot of product, discard any remaining inventory and return the enclosed response form. Contact the Customer Service Department at 800-637-3375, ext. 10, 12, or 31 for assistance with this recall.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- GGP
- Quantity affected
- 63 kits
- Distribution
- Nationwide Distribution-including the states of FL, IN, NC, OH, UT, and WA.
- Date initiated
- 2012-10-24
- Date posted
- 2012-12-03
- Date terminated
- 2013-01-08
- Location
- Stamford, CT
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SPECTROLYSE PAI-1, MODEL 101201 (K063323) | American Diagnostica, Inc. | 2007-08-15 |